Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma
Information source: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma; Metastasis; Invasion
Intervention: Colchicine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Kaohsiung Medical University Chung-Ho Memorial Hospital Official(s) and/or principal investigator(s):
Zu Y Lin, MS, Principal Investigator, Affiliation: Kaohsiung Medical University
Overall contact:
Zu Y Lin, MS, Phone: 886-7-323-4553, Email: linzuyau@yahoo.com.tw
Summary
This trial is to evaluate the potential of colchicine for the palliative management of
hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the
Department of Health R. O.C. approved doses and methods of administration.
Clinical Details
Official title: Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: overall survival
Secondary outcome: Number of participants with adverse events
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. . Patient has at least one of the following criteria: (1) positive for hepatocellular
carcinoma evidenced by cytology or pathology, (2) serum alpha-fetoprotein level > 400
ng/mL and has evidence of hepatocellular carcinoma provided by contrast-enhanced
computed tomography or magnetic resonance imaging.
2. . Contrast-enhanced computed tomography or magnetic resonance imaging has evidence of
distant metastasis or large vessel invasion caused by hepatocellular carcinoma.
3. . Patient has Child A hepatic reserved function
Exclusion Criteria:
1. . There are life-threatening hemorrhage including gastrointestinal hemorrhage and
hemorrhage from other vital organs such as lungs or brain.
2. . There are life-threatening bacterial, fungal or viral infection (not included
hepatitis B and C virus).
3. . Patient has serum creatinine level > 1. 5 mg/dL.
4. . Patient must receive long-term medication of statin or fibrates drugs and these
medications can not be changed.
5. . Patient has white blood cell count < 1500/µL, platelet count < 30000/µL or
hemoglobin < 9. 0 gm/dL after medication.
6. . Pregnant woman or plan to be a pregnant woman
7. . allergy to colchicine or has history of severe side effects caused by colchicine
8. . Patient has received systemic chemotherapy within 2 months before enrollment or
plans to receive systemic chemotherapy in the future.
9. . Patient is under or plans to receive Nexavar or other clinical trial testing drug.
10. . Patient has severe malfunction of vital organs and can not participate in this
study justified by the doctor in this research team.
11. . Patient is under or plans to receive Chinese traditional medicine or herb drugs.
Locations and Contacts
Zu Y Lin, MS, Phone: 886-7-323-4553, Email: linzuyau@yahoo.com.tw
Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan; Recruiting
Z Y Lin, MS, Phone: 886-7-323-4553, Email: linzuyau@yahoo.com.tw
Zu Y Lin, MS, Principal Investigator
W L Chuang, PhD, Sub-Investigator
M L Yu, PhD, Sub-Investigator
S C Chen, PhD, Sub-Investigator
C Y Dai, PhD, Sub-Investigator
M L Yeh, MD, Sub-Investigator
J F Huang, PhD, Sub-Investigator
M Y Hsieh, MS, Sub-Investigator
Additional Information
Related publications: Lin ZY, Wu CC, Chuang YH, Chuang WL. Anti-cancer mechanisms of clinically acceptable colchicine concentrations on hepatocellular carcinoma. Life Sci. 2013 Sep 3;93(8):323-8. doi: 10.1016/j.lfs.2013.07.002. Epub 2013 Jul 16.
Starting date: August 2013
Last updated: May 19, 2015
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